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Skin Cancer

Using the New Melanoma Drugs in the Clinic

With two effective new treatments for advanced melanoma, the question has become how to best use them and how to manage their toxicities.  Vemurafenib (Zelboraf) and ipilimumab (Yervoy)1 have different pharmacokinetics, which lend themselves to different patient types. Omid Hamid, MD, of The...

Skin Cancer

Novel BRAF Inhibitor Receives FDA Approval in Metastatic Melanoma

Vemurafenib (Zelboraf) received FDA approval on August 17, 2011, for treatment of metastatic or unresectable melanoma, based on the results of the phase III BRIM3 trial.1 BRIM3 compared vemurafenib to dacarbazine in 675 untreated patients with the BRAF V600E mutation. Vemurafenib targets the...

Skin Cancer

Novel Drugs Ipilimumab and Vemurafenib for Advanced Melanoma

In this introductory installment of In the Clinic, The ASCO Post provides an overview of two new melanoma agents recently approved by FDA, with discussion on pivotal data leading to approval, dosage and administration, and managing drug-related toxicities. Watch for more on clinical use of novel...

Skin Cancer

Adjuvant Treatment Still Standard in Melanoma, but New Drugs Prolong Life in Metastatic Setting

At the Best of ASCO® Miami meeting, Omid Hamid, MD, The Angeles Clinic and Research Institute (www.theangelesclinic.org), Los Angeles, California, reviewed abstracts that received a great deal of attention at this year’s Annual Meeting—the new treatments for metastatic melanoma. He also described...

Skin Cancer

‘Breakthrough’ Approach to Advanced Basal Cell Carcinoma via Inhibition of Hedgehog Pathway

The first-in-class Hedgehog pathway inhibitor vismodegib appears to be a successful treatment for advanced basal cell carcinoma, a disfiguring and debilitating disease, according to a pivotal multicenter nonrandomized trial presented as a Best Abstract at a Presidential Session during the recent...

Skin Cancer

Investigators Unlocking the Mysteries of Merkel Cell Carcinoma

Researchers at the University of Pittsburgh Cancer Institute have documented the molecular activity through which the Merkel cell polyomavirus contributes to 80% of cases of Merkel cell carcinoma—a finding that holds promise for future therapies. The researchers are now working on testing more than ...

Skin Cancer

Gathering Data Point to Potential Advantages of Vismodegib in Basal Cell Carcinoma and Other Advanced Cancers

Vismodegib is a small-molecule, orally active hedgehog pathway inhibitor that has shown considerable promise in treating basal cell carcinoma and is currently being evaluated alone and in combination in early-phase trials in medulloblastoma and a long list of other cancers.1 Owing to its...

Skin Cancer

Physician-based Screening Leads to the Detection of Thinner Melanomas with More Favorable Prognosis

Physician-based screening leads to detection of thinner melanomas that were less likely to have negative prognostic attributes such as ulceration and dermal mitosis, according to a retrospective review of patient records and biopsy logs from 394 patients diagnosed with cutaneous melanoma. The...

Skin Cancer

Sentinel Lymph Node Biopsy for Thin Melanomas?

When sentinel lymph node biopsy for the regional staging of melanoma was first introduced, it was recommended for any patient with a melanoma 1.0 mm in Breslow thickness or greater. Patients with thin melanomas were not thought to have a sufficiently high risk to warrant the additional cost and...

Skin Cancer

Cancer Survivors at Greater Risk for Cutaneous Melanoma

Patients with a previously diagnosed cancer have an increased risk of developing cutaneous melanoma, with the highest risk among patients who have had a prior diagnosis of melanoma, according to a report published in the Archives of Dermatology.1 Key Findings Using Surveillance, Epidemiology, and...

Skin Cancer

Ingenol Mebutate Approved for Topical Actinic Keratosis Therapy

The FDA has approved ingenol mebutate (Picato) gel for the topical treatment of actinic keratosis. At a concentration of 0.015%, the gel is used once daily on the face and scalp for 3 consecutive days, whereas a 0.05% dosage form is used once daily on the trunk and extremities for 2 consecutive...

Skin Cancer

FDA Approves Vismodegib for Basal Cell Carcinoma

The FDA has approved vismodegib (Erivedge) to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients with metastatic...

Skin Cancer

What You Should Know about Peginterferon Alfa-2b for Adjuvant Treatment of Melanoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication Peginterferon alfa-2b (PegIntron, Sylatron) was recently ...

Skin Cancer

Expert Point of View: Answer to Secondary Cancers with RAF Inhibitors May Be Concomitant MEK Inhibition

“The development of nonmelanoma skin cancers secondary to RAF inhibitor treatment has been recognized since 2005, having been seen initially with sorafenib (Nexavar),” noted Mario E. Lacouture, MD, of Memorial Sloan-Kettering Cancer Center. Commenting on recently published studies in this setting,...

Skin Cancer

Answer to Secondary Cancers with RAF Inhibitors May Be Concomitant MEK Inhibition

Keratoacanthomas and cutaneous squamous cell carcinomas are frequently observed in patients receiving the RAF inhibitor vemurafenib (Zelboraf) for treatment of BRAF-mutated melanoma. As discussed by Lacouture and colleagues in a recent Journal of Clinical Oncology article, these effects appear to...

Breast Cancer
Kidney Cancer
Lung Cancer
Skin Cancer
Leukemia
Lymphoma
Issues in Oncology

NCCN Clinical Practice Guidelines: Important Updates for 2012

The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology have become the most widely used guidelines in oncology practice. The Guidelines cover 97% of all patients with cancer and are continually updated by expert panels. The 2012 Guidelines include some completely...

Skin Cancer

Dual BRAF and MEK Inhibition Is Active in Advanced Melanoma

In advanced melanoma, combination therapy with two investigational drugs—one targeting BRAF and the other the MEK pathway—achieved a median progression-free survival of 7.4 months, which rose to 10.8 months in patients who were optimally dosed, reported Jeffrey S. Weber, MD, PhD, Director of the...

Skin Cancer

MEK Inhibitor Reduces Progression of BRAF-mutated Melanoma and Might also Benefit Others

In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. The MEK inhibitor trametinib...

Skin Cancer

Landscape for Treatment of Metastatic Melanoma Is Expanding

Metastatic melanoma was long considered untreatable and incurable. The FDA approval of ipilimumab (Yervoy) and vemurafenib (Zelboraf) ushered in a new era for this disease, and now additional treatment options are in late stages of clinical development. Dabrafenib, a novel oral BRAF inhibitor, and...

Hepatobiliary Cancer
Skin Cancer

NDA for Chemosaturation System to Treat Melanoma in the Liver

Delcath Systems, Inc, announced that it has submitted a New Drug Application (NDA) to the FDA, seeking approval for its chemosaturation system (CHEMOSAT) for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. The system is designed to...

Skin Cancer

Importance of Dermatologic Care for Patients with Cancer

I first became interested in treating skin issues associated with cancer about 10 years ago, during my dermatology residency training at the University of Chicago. Many of the agents under clinical development at the time, such as cetuximab (Erbitux) or sorafenib (Nexavar), were causing...

Skin Cancer

Exciting New Agents Offer Further Treatment Options for Metastatic Melanoma

“This is a very exciting time in melanoma,” said Michael Sabel, MD, of the University of Michigan, Ann Arbor. “For years, we chugged along with few options for systemic therapy. Then in 2010 and 2011, we saw melanoma data presented at ASCO plenary sessions. At ASCO 2012, we expanded in these areas...

Skin Cancer
Survivorship

Radiation to the Skin and Later Risk of Basal Cell Carcinoma Studied

The likelihood of developing basal cell carcinoma was approximately 40 times higher among participants of the Childhood Cancer Survivor Study (CCSS) who received a dose of 35 Gy or more to the skin from radiation therapy than survivors who were not treated with radiation, according to a study...

Skin Cancer

Vismodegib: Novel Agent for Treating Advanced Basal Cell Carcinoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In January 2012, vismodegib (Erivedge) was approved...

Skin Cancer

Combination of BRAF and MEK Inhibitors Paves Way for Phase III Studies in BRAF-mutated Metastatic Melanoma

Two late-breaking studies presented at the 2012 European Society for Medical Oncology (ESMO) Congress highlight the promising potential of combining dual BRAF and MEK inhibitors for the treatment of BRAF-mutated metastatic melanoma. A phase II study showed that combining full doses of the BRAF...

skin cancer

Prevention and Treatment of Multikinase Inhibitor–induced Hand-Foot Syndrome

Multikinase inhibitors (sorafenib [Nexavar], sunitinib [Sutent], pazopanib [Votrient], axitinib [Inlyta], regorafenib [Stivarga]) block various proteins including vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR). They have been approved by...

skin cancer

Tremelimumab Not Better Than Standard-of-care Chemotherapy in Patients with Advanced Melanoma 

Tremelimumab did not produce a statistically significant advantage in overall survival compared to first-line standard-of-care chemotherapy in a phase III randomized trial reported in the Journal of Clinical Oncology. At final analysis, median overall survival by intent to treat was 12.6 months...

skin cancer

Vemurafenib-resistant BRAF-mutant Melanoma

Mutational activation of BRAF is the most prevalent genetic alteration in melanoma, with ≥ 50% of tumors expressing the BRAF(V600E) oncoprotein. Vemurafenib (Zelboraf) produces tumor regression and improved survival in patients with late-stage BRAF-mutated melanoma. However, most patients relapse...

skin cancer

Trametinib Shows Activity in Previously Treated but BRAF Inhibitor–naive BRAF-mutant Melanoma

In a multicenter phase II study, trametinib showed “significant clinical activity” in a cohort of BRAF inhibitor–naive patients with BRAF-mutant cutaneous melanoma previously treated with chemotherapy and/or immunotherapy. Only minimal clinical activity, however, was observed among a cohort of...

skin cancer

New Data Reported on Melanoma, Cutaneous T-cell Lymphoma, Basal Cell Carcinoma, and Cancer Treatment Side Effects 

At the recent American Academy of Dermatology 71st Annual Meeting in Miami Beach, researchers presented interesting findings regarding melanoma and other skin cancers. The ASCO Post brings you the following news briefs on these topics. Melanoma Incidence Decreases among Adolescents and Children...

breast cancer
skin cancer

FDA Approves New Radioactive Diagnostic Imaging Agent to Help Locate Lymph Nodes in Patients with Certain Cancers

The FDA has approved technetium Tc 99m tilmanocept (Lymphoseek Injection), a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. Tilmanocept is an imaging drug that...

skin cancer

Alopecia a Common but Underreported Side Effect of Endocrine Agents 

At the recent American Academy of Dermatology Annual Meeting in Miami, researchers presented interesting findings regarding melanoma and other skin cancers, as well as dermatologic effects of cancer agents. The following is a summary of one such study. While alopecia is a common side effect of...

skin cancer

Sentinel Node Biopsy in Melanoma: Essential or Optional? 

Is sentinel node biopsy in melanoma an essential component of care? Despite a large multinational trial and recently published or updated guidelines, the question is still a thorny one according to experts who debated the issue at the recent meeting of the Society of Surgical Oncology in...

skin cancer

Does Every Melanoma Patient with a Positive Sentinel Node Need More Lymph Nodes Removed? 

When sentinel node biopsy was shown to predict whether early melanoma had spread to regional lymph nodes, it revolutionized care. Before that, dissection of all regional lymph nodes was the norm for most patients. After that, the standard of care became a sentinel node biopsy and then—only if the...

skin cancer

Nonmelanoma Skin Cancer May Be Associated with Modest Increased Risk of Secondary Cancer: Further Study Needed

A prospective study by researchers at Brigham and Women’s Hospital observed an association between risk of second primary cancer and history of nonmelanoma skin cancer in white men and women. The researchers found that people with a history of nonmelanoma skin cancer had a modestly increased risk...

skin cancer

Prevention and Treatment of Acneiform Rash Caused by EGFR Inhibitors 

Dermatologic Events in Oncology is guest edited by Mario E. Lacouture, MD, an Associate Member in the Division of Dermatology, Department of Medicine, at Memorial Sloan-Kettering Cancer Center, New York. He is a board-certified dermatologist with a special interest in dermatologic conditions that...

skin cancer

Breakthrough Therapy Designation for Lambrolizumab for the Treatment of Advanced Melanoma

Merck has announced that the U.S. Food and Drug Administration (FDA) has designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting the programmed death receptor (PD-1) that...

skin cancer

Inflammatory Bowel Disease Raises Risk of Melanoma

Patients with inflammatory bowel disease are at higher risk of melanoma, reported researchers at Mayo Clinic. Researchers found that inflammatory bowel disease is associated with a 37% greater risk for the disease. The findings were presented at the Digestive Disease Week 2013 conference in...

Skin Cancer

Trametinib in Unresectable or Metastatic Melanoma with BRAF V600E or BRAF V600K Mutation

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On May 29, 2013, trametinib (Mekinist) was approved by...

skin cancer

Dabrafenib for Unresectable or Metastatic Melanoma with BRAF V600E Mutation 

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.  Indication On May 29, 2013, dabrafenib (Tafinlar) was approved...

skin cancer

FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer

The U.S. Food and Drug Administration (FDA) recently approved two new drugs, dabrafenib (Tafinlar) and trametinib (Mekinist), for patients with advanced or unresectable melanoma. Dabrafenib, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors express the BRAF V600E gene...

skin cancer

MEK Inhibitor Improves Outcomes in Metastatic Uveal Melanoma 

For the first time, a drug has proven effective in the treatment of uveal (ocular) melanoma that has metastasized, according to a randomized multicenter phase II study presented at the 2013 ASCO Annual Meeting.1 “This study is the first to demonstrate an improved clinical outcome with any systemic ...

Skin Cancer

GM-CSF Boosts Survival Benefit of Ipilimumab in Metastatic Melanoma 

For metastatic melanoma, the activity of ipilimumab can be boosted by the addition of granulocyte-macrophage colony-stimulating factor (GM-CSF, Leukine), according to a phase II study that found the combination improved overall survival, vs ipilimumab alone. The results were presented at the 2013...

skin cancer

'Spectacular' Results with Immunotherapies in Melanoma Galvanize the Oncology Community 

In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. Much of the news about...

skin cancer

Melanomas Induced by BRAF Inhibitors 

Dermatologic Events in Oncology is guest edited by Mario E. Lacouture, MD, an Associate Member in the Division of Dermatology, Department of Medicine, at Memorial Sloan-Kettering Cancer Center, New York. He is a board-certified dermatologist with a special interest in dermatologic conditions that...

gynecologic cancers
skin cancer

ASCO Impact Report Indicates Strong Interest in New Treatments for Melanoma and Cervical Cancer 

New treatments for melanoma and cervical cancer were cited as the most important subjects of new clinical information presented at the 2013 ASCO Annual Meerting, according to the second annual ASCO Impact Report released recently by Encuity Research.  New treatments for melanoma, with an emphasis...

Breast Cancer
Skin Cancer
Multiple Myeloma
Supportive Care
Gastroesophageal Cancer

New Research Presented in Breast, Gastric, Esophageal Cancers, Melanoma, and Multiple Myeloma, plus Supportive Care 

Attendees at the ASCO Annual Meeting are faced with a major challenge of trying to attend as many important sessions as they can over a 4-day period. Our challenge is to feature the major news in The ASCO Post. In addition to our regular comprehensive coverage of key presentations, the following...

skin cancer

Anti-PD-1 Antibody Lambrolizumab Produces Durable Responses with Low Toxicity in Patients with Advanced Melanoma  

Lambrolizumab produced a high rate of sustained tumor regression when tested among 135 patients with advanced melanoma in a multi-institutional, international, phase I expansion study reported in The New England Journal of Medicine. At a median follow-up of 11 months, responses were durable in the...

skin cancer

'Alarming Difference' in Survival Outcomes for Young White Men with Melanoma 

An “alarming difference” in survival outcomes between young, non-Hispanic white males and females with primary invasive melanoma “highlights the urgent need for both behavioral interventions to promote early detection strategies in young men and further investigation of the biological basis for the ...

skin cancer

Enhanced Treatment, Surveillance Needed for Patients With BRAF-Mutant Melanoma to Prevent Secondary Cancers

Researchers at Moffitt Cancer Center suggest secondary cancers seen in melanoma patients who are being treated for a BRAF gene mutation may require new strategies, such as enhanced surveillance and combining BRAF inhibitor therapy with other inhibitors, especially as they become more widely used....

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